K014297 is an FDA 510(k) clearance for the ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on July 9, 2002, 190 days after receiving the submission on December 31, 2001.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K014297 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 2001 |
| Decision Date | July 09, 2002 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNT — Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |